Durvalumab

Generic Name
Durvalumab
Brand Names
Imfinzi
Drug Type
Biotech
Chemical Formula
-
CAS Number
1428935-60-7
Unique Ingredient Identifier
28X28X9OKV
Background

Durvalumab is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody and a novel immune-checkpoint inhibitor for cancer treatment. Produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cell suspension culture, durvalumab is a programmed death-ligand 1 (PD-L1) blocking antibody that works to promote normal immune responses that attack tumour cells.

Durvalumab is marketed under the brand name Imfinzi, which is available for intravenous injections. It was granted accelerated approval by the FDA in May 2017 for the treatment of selected patients with locally advanced or metastatic urothelial carcinoma. In September 2018, durvalumab was approved by the EMA for the treatment of adult patients with locally advanced, unresectable non-small cell lung cancer (NSCLC), only if PD-L1 is expressed in ≥ 1% of tumour cells and there was no observable disease progression following platinum-based chemoradiation therapy. On March 27, 2020, durvalumab was approved by the FDA for use in combination with etoposide and either carboplatin or cisplatin as first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).

Indication

Durvalumab is indicated for the treatment of adults with the following conditions:

Associated Conditions
Extensive-stage Small Cell Lung Cancer (SCLC), Locally Advanced Biliary Tract Cancer, Metastatic Biliary Tract Cancer, Metastatic Non-Small Cell Lung Cancer, Unresectable Hepatocellular Carcinoma (HCC), Unresectable Stage III Non-small Cell Lung Cancer, Unresectable, locally advanced PD-L1 positive Lung Cancer Non-Small Cell Cancer (NSCLC)
Associated Therapies
First Line Chemotherapy

Non Small Cell Lung Cancer Trial of Durvalumab and Tremelimumab in Advanced Epidermal Growth Factor Receptor (EGFR) Mutant Disease.

First Posted Date
2019-06-21
Last Posted Date
2023-04-21
Lead Sponsor
University of Sydney
Target Recruit Count
100
Registration Number
NCT03994393
Locations
🇦🇺

Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia

🇦🇺

St Vincent's Hospital (Melbourne), Melbourne, Victoria, Australia

🇨🇳

Taiwan Dalin Tzu Chi Hospital, Chiayi City, Taiwan

and more 13 locations

Study of Olaparib and Durvalumab in IDH-Mutated Solid Tumors

First Posted Date
2019-06-19
Last Posted Date
2024-07-18
Lead Sponsor
University Health Network, Toronto
Target Recruit Count
58
Registration Number
NCT03991832
Locations
🇨🇦

Princess Margaret Cancer Centre, Toronto, Ontario, Canada

A Study Comparing Immunotherapy With Chemotherapy in the Treatment of Elderly Patients With Advanced NSCLC (MILES-5)

First Posted Date
2019-06-05
Last Posted Date
2023-03-24
Lead Sponsor
National Cancer Institute, Naples
Target Recruit Count
460
Registration Number
NCT03975114
Locations
🇮🇹

Istituto Nazionale Tumori, IRCCS, Fondazione G. Pascale, Napoli, Italy

A Study of Tivozanib in Combination With Durvalumab in Subjects With Advanced Hepatocellular Carcinoma

Phase 1
Terminated
Conditions
Interventions
First Posted Date
2019-05-31
Last Posted Date
2023-07-12
Lead Sponsor
AVEO Pharmaceuticals, Inc.
Target Recruit Count
27
Registration Number
NCT03970616
Locations
🇺🇸

University of California - Irvine, Orange, California, United States

🇺🇸

Banner MD Anderson Cancer Center, Gilbert, Arizona, United States

🇺🇸

City of Hope, Duarte, California, United States

and more 7 locations

Immunotherapy, Chemotherapy, Radiotherapy and Surgery for Synchronous Oligo-metastatic NSCLC

First Posted Date
2019-05-29
Last Posted Date
2024-12-20
Lead Sponsor
ETOP IBCSG Partners Foundation
Target Recruit Count
96
Registration Number
NCT03965468
Locations
🇨🇭

Kantonsspital Winterthur, Winterthur, Switzerland

🇮🇹

European Institute of Oncology, Milano, Italy

🇮🇹

Istituto Oncologico Veneto - Irccs, Padova, Italy

and more 12 locations

Clinical Trial Evaluating FOLFIRI + Durvalumab vs FOLFIRI + Durvalumab and Tremelimumab in Second-line Treatment of Patients With Advanced Gastric or Gastro-oesophageal Junction Adenocarcinoma

First Posted Date
2019-05-22
Last Posted Date
2024-07-08
Lead Sponsor
Federation Francophone de Cancerologie Digestive
Target Recruit Count
107
Registration Number
NCT03959293
Locations
🇫🇷

Ch - Hôpital Claude Bernard, Albi, France

🇫🇷

Chu - Hôpital Sud, Amiens, France

🇫🇷

Privé - Clinique de L'Europe, Amiens, France

and more 32 locations

A Study of MEDI1191 in Sequential and Concurrent Combination With Durvalumab in Subjects With Advanced Solid Tumors

First Posted Date
2019-05-13
Last Posted Date
2024-10-02
Lead Sponsor
MedImmune LLC
Target Recruit Count
61
Registration Number
NCT03946800
Locations
🇪🇸

Research Site, Pamplona, Spain

Combined Treatment of Durvalumab, Bevacizumab, Tremelimumab and Transarterial Chemoembolization (TACE) in Subjects With Hepatocellular Carcinoma or Biliary Tract Carcinoma

First Posted Date
2019-05-06
Last Posted Date
2024-12-20
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
22
Registration Number
NCT03937830
Locations
🇺🇸

National Institutes of Health Clinical Center, Bethesda, Maryland, United States

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